Manufacturing Supervisor, Upstream

The role

This person will lead, coach, and mentor the Upstream manufacturing team. They will oversee vector upstream manufacturing activities, including batch execution, resource scheduling, and equipment preparation.

What you will do

• Provide leadership, coaching, and mentoring of Upstream manufacturing personnel.
• Oversee and execute Vector Upstream Manufacturing activities.
• Provide on the floor training and support for upstream manufacturing operations.
• Hire, coach, and develop Manufacturing team members.
• Monitor and report on area performance and implement process improvements.
• Design, implement, maintain, and improve vector manufacturing systems, policies, and procedures.
• Identify and mitigate risks in Manufacturing operations.
• Manage the Manufacturing Production system including deviations, root cause analysis, CAPAs, and Change Controls.
• Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP.
• Perform other duties as assigned.

Required qualifications

• Prior leadership experience in GMP manufacturing facility
• Hands-on experience in writing and reviewing the documentation
• Experience in (bio)-manufacturing unit operations
• Good writing and oral communication skills
• BS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study
• 4-6 years of related work experience in a GMP environment
• 1 year of supervisory experience
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
• Ability to manage multiple priorities
• Ability to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Ability to lift up to 25 pounds frequently and 40-50 pounds occasionally
• Corrected 20/20 vision to assist with visual inspection of Drug Products

Nice to have

• Viral Vector Manufacturing preferred
• Knowledge and experience with the use and troubleshooting of Cytiva XDR 50L, Cytiva XDR 500L, Univercells Scale-X Carbo, and Cytiva iCELLis 500 bioreactors
• Work experience in a comparable position, preferentially in an industrial organization
• In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting
• Drug Substance experience with cell culture and upstream viral vector manufacturing
• Experience using single use systems

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life, and personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Before you apply

• Criminal background check required
• Not able to sponsor visas

About the company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials.